Yantai, China, May 4, 2023 – Boan Biotech today announced that an international multi-center Phase 3 clinical study for its in-house developed Denosumab Injection (BA6101; BA1102) has been initiated in Europe, the United States, and Japan, and recently the first patient in (FPI) was achieved.
BA6101 and BA1102 are biosimilar products to Prolia® and Xgeva®, respectively. Prolia® has been approved worldwide for the following indications: ①Treatment of postmenopausal women with osteoporosis at high risk for fracture. In postmenopausal women, Prolia® significantly reduces the risk of vertebral, non-vertebral, and hip fractures; ② Treatment to increase bone mass in men with osteoporosis at high risk for fracture; ③ Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; ④ Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; ⑤ Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Xgeva® has been approved worldwide for the following indications: ① Prevention of skeletal-related events in patients with bone metastases from solid tumors; ② Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; ③ Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
This international multi-center Phase 3 study is a randomized, double-blind, parallel-group, reference-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Boan Biotech’s biosimilar product compared with the reference product. According to the Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product1 issued by FDA, the Guideline on similar biological medicinal products2 issued by EMA, the Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics3 issued by PMDA and based on the discussion with FDA, EMA and PMDA, after completion of the Phase 3 clinical study, BA6101 and BA1102 can apply and be approved for all same indications as Prolia® and Xgeva® in Europe, the United States, and Japan.
Previously, BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world. The product was awarded “Top 10 Biopharmaceutical Advancements in China” and the results of the two Phase 1 clinical studies of Boyoubei® were published in Expert Opinion on Investigational Drugs4 and Frontiers in Pharmacology5, respectively. Additionally, Boyoubei®’s Phase 3 clinical study was published in Journal of Orthopaedic Translation6. BA1102's Biologics License Application (BLA) was also accepted by the Center for Drug Evaluation of the National Medical Products Administration of China in March 2023.
Based on the huge patient demand and proven clinical value of the drug, Boan Biotech believes that denosumab presents a broad market prospect on a global scale. According to public available data, Prolia® and Xgeva® had global sales of $3.63 billion and $2.01 billion respectively in 2022.
Dr. Dou Changlin, President of R&D and Chief Operating Officer of Boan Biotech, said: “At Boan Biotech, we’re committed to serving patients around the world with high-quality biologics. BA6101 and BA1102 are in-house developed by the company in accordance with the regulations of China, the United States, the European Union and Japan. The initiation of the international Phase 3 clinical trial is another milestone for Boan Biotech to seek global development. We will accelerate the clinical development of these two products as well as the strategic planning for the subsequent introduction of more biologics into the global markets in order to build a leading Chinese biopharmaceutical brand around the world.”
Note: FDA is the US Food and Drug Administration, EMA is the European Medicines Agency, and PMDA is Japanese Pharmaceuticals and Medical Devices Agency
 FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015
 EMA. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 2015
 PMDA. Guideline for the quality, safety, and efficacy assurance of follow-on biologics. 2009
 Wang S, Yang X, Huang J, et al. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. Expert Opin Investig Drugs. 2022;31: 1133-1142.
 Niu S, Chen M, Yan D, et al. A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults. Frontiers in Pharmacology. 2022;13: 893166.
 Gu J, Zhang H, Xue Q, et al. Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study. Journal of Orthopaedic Translation. 2023; 38: 117-125.